Paragon Europe is seeking to recruit a Senior Associate Regulatory Intelligence for one of our clients within the Healthcare industry.
Responsible for Regulatory Intelligence Surveillance & Systems operations. This includes monitoring and interpreting global information for impact to our client’s company, ensuring timely dissemination and continuously monitoring (e.g., dashboard) to ensure a state of control and leadership awareness. Distinguishes key, priority topics from a myriad of sources and published information. Conducts research on specific topics requested by RA or LRS leadership. Ensures that regulatory intelligence is effectively detected, communicated and actioned by assigned “owners” to deliver compliance and strategic results.
Essential Duties and Responsibilities:
Supports development and implementation of the process for managing global Regulatory Intelligence in the company.
Conducts monitoring to compile global regulatory information, including timely detection, communication and action within the company.
Maintains systems to track, trend and continuously monitor the status of the company’s actions on intelligence, compliance and advocacy targets.
Deliver periodic intelligence reports, program updates, presentations, newsletters and other information/media updates as assigned.
Provides technical support for the Regulatory Intelligence & Surveillance function such as:
Develops, establishes and/or maintains databases, spreadsheets, SharePoint Sites and website information and acts as dedicated support for technology platforms.
Provides data entry and input into the scorecard and metrics database. Ensures data integrity for management reports and provides a compilation of data for metrics and management reviews. May also provide data entry for other databases upon request or as needed.
Provides training and training materials for database, spreadsheet and technology vehicle usage to all key stakeholders
May work with internal and external experts to disseminate periodic reports, survey results, email updates focusing on summary news and information, and Frequently Asked Questions (FAQs).
May provide support in searching and evaluating new and revised regulations / rulings / directives, guidance documents and regulatory initiatives related to Health Authorities that may impact the company’s quality systems, regulatory filings or commercial plans.
May assist in tracking key developments from Health Authorities, trade associations, special interest groups and other external parties.
Continuously refine/improve the framework and actions.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
List knowledge, skills, and/or abilities required:
Minimum BS/equivalent in a scientific discipline.
Excellent verbal and written communication skills
Independence, critical thinking, analytical and problem-solving skills
Experience working in a matrixed work environment finding innovative solutions to challenging business problems
Education and/or Experience:
Minimum 3 years’ experience in a regulated environment, cross-region preferred, interpreting and applying regulatory requirements. Drug and/or medical device preferred